Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
10.3760/cma.j.cn501113-20240807-00365
- VernacularTitle:延长或转换为艾米替诺福韦治疗在慢性乙型肝炎患者中的疗效评估：一项Ⅲ期随机对照研究
- Author:
Zhihong LIU
1
;
Qinglong JIN
;
Yuexin ZHANG
;
Guozhong GONG
;
Guicheng WU
;
Lvfeng YAO
;
Xiaofeng WEN
;
Zhiliang GAO
;
Yan HUANG
;
Daokun YANG
;
Enqiang CHEN
;
Qing MAO
;
Shide LIN
;
Jia SHANG
;
Huanyu GONG
;
Lihua ZHONG
;
Huafa YIN
;
Fengmei WANG
;
Peng HU
;
Xiaoqing ZHANG
;
Qunjie GAO
;
Chaonan JIN
;
Chuan LI
;
Junqi NIU
;
Jinlin HOU
Author Information
1. 华南传染病防治教育部重点实验室 南方医科大学南方医院，广州 510515
- Keywords:
Hepatitis B virus;
Tenofovir amibufenamide;
Chronic hepatitis B;
Therapeutic
- From:
Chinese Journal of Hepatology
2024;32(10):883-892
- CountryChina
- Language:Chinese
-
Abstract:
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
